A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

  • STATUS
    Recruiting
  • End date
    Jan 16, 2024
  • participants needed
    2200
  • sponsor
    AstraZeneca
Updated on 22 September 2022
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (8.4 mi away) Contact
+234 other location

Summary

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care

Description

This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort® pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2200 participants will be randomized globally.

Details
Condition Asthma
Treatment BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg, BFF pMDI 320/9 μg
Clinical Study IdentifierNCT04609878
SponsorAstraZeneca
Last Modified on22 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1
12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control
Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1
FEV1 post-albuterol at V2 or V3 (if repeat needed)
ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization)
Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL
FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)
Participants > and/or = 18 years of age: < 80%
Participants 12 to <18 years of age: < 90%
Participants 12 to <18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3
Note: Reversibility testing is still required at Visit 2 and/or Visit 3, even if the patient has documented historical reversibility reported in the 12 months prior to Visit 1
Willing and, in the opinion of the Investigator, able to adjust current asthma
therapy, as required by the protocol
Demonstrate acceptable MDI/pMDI administration technique
Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation)
eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization)
No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization

Exclusion Criteria

Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1
a. Participants where, in the opinion of the Investigator, treatment with biological
therapy for asthma would be appropriate
b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1
whichever is longer and must not be used during study duration
Current smokers, former smokers with >10 pack-years history, or former smokers who
stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or
other vaping devices, and marijuana)
Current evidence of Chronic Obstructive Pulmonary Disease (COPD)
a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1
b. Use of systemic corticosteroids for any other reason except for the acute treatment of
severe asthma exacerbation is prohibited for the duration of the study
c. Depot corticosteroid use for any reason within 12 months of V1
Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled
combination therapy, in the 12 weeks prior to V1
Narrow angle glaucoma not adequately treated and/or change in vision that may be
Use of oral b2-agonist within 3 months of V1
relevant, in the opinion of the Investigator, within 3 months of Visit 1
Use of any immunomodulators or immunosuppressive medication within 3 months or 5
Life-threatening asthma defined as a history of significant asthma episode(s) requiring
half-lives, whichever is longer, and must not be used during the study duration
intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or
asthma-related syncopal episode(s)
Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does
Hospitalization for asthma within 2 months of Visit 1
not agree to stop during the study duration
Known history of drug or alcohol abuse within 12 months of Visit 1
Regular use of a nebulizer or a home nebulizer for receiving asthma medications
Participants with a known hypersensitivity to beta2-agonists, corticosteroids
anticholinergics, or any component of the MDI or pMDI
Study Investigators, sub-Investigators, coordinators, and their employees or immediate
Participation in another clinical study with an Investigational Product
family members
Please refer to the study protocol for the complete inclusion and exclusion criteria list
For women only - currently pregnant (confirmed with positive highly sensitive pregnancy
test), breast-feeding, or planned pregnancy during the study or not using acceptable
contraception measures, as judged by the Investigator
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